3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars

NCT06047925 | Completed

• 1 other identifier: FDASU-RECID022321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars

Conditions

3D Printed Crowns

Keywords

3D printed crowns- Stainless steel crowns

Outcome Measures

Primary Outcomes (1)

• The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars

  Evaluation of clinical performance of both crowns regarding gingival health (gingival \& plaque index) and Fracture, retention, marginal discoloration and surface texture according to the modified United states Public Health Service (USPHS) criteria. 3,6-12 and 18 months.

  3,6,12 and 18 months

Secondary Outcomes (1)

• Patient and parent satisfaction.

  Immediately ,3,6,12&18 months

Study Arms (2)

group A

EXPERIMENTAL

First permanant molar will be prepared to receive 3D printed crown

Procedure: 3D printed crown

group B

ACTIVE COMPARATOR

First permanant molar will be prepared to receive SSC

Procedure: stanless steel crown

Interventions

3D printed crown PROCEDURE

Reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance by 1 mm. Reduction will be performed by 1 mm on the mesial, distal, buccal and lingual surfaces of the tooth. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. Temporary crown will be placed above the preparation as temporisation.The impression will be sent to the lab .The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.The crown will be printed using 3D printer using hybrid resin(micro-filled hybrid material) material.The 3d printed crown is cemented with resin cement.

group A

stanless steel crown PROCEDURE

The occlusal surface of the tooth should be reduced by about 1.5 mm, maintaining its occlusal contour or until the tooth is out of occlusion with adequate room to fit a crown.Proximally, tooth reduction will be made through the mesial and distal contact areas, then roundation of line angles to avoid the creation of ledges or steps.The crown selection will be done by trial and error or by measuring the mesiodistal dimension of the tooth space with dividers. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in.

group B

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children included in the study should conform to the following criteria:
• Badly broken-down endodontically treated first permanent molar
• First permanent molar with extensive multi-surface caries.
• First permanent molar with structural developmental defects such as hypoplasia, Molar-Incisor Hypomineralization (MIH), Amelogenesis Imperfecta, and Dentinogenesis Imperfecta

You may not qualify if:

• Children who are uncooperative needing sedation or general anesthesia.
• Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
• Molars of poor prognosis

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ainshams university

Cairo, 11361, Egypt

Location

Study Officials

• Nagwa khattab, BDS,MSc,MD

  Ainshams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Investigator-outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant lecturer

Model Details: one experimental group and one active comparator group

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: July 17, 2026

Record last verified: 2024-11

Locations

EG (1)